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FDA NDA · NDA203565

INJECTAFER

ferric carboxymaltose injection

Sponsor: AM REGENT

APPLICATION
NDA203565
TYPE
NDA
ORIGINAL APPROVAL
2013-07-25
LATEST ACTION
2025-01-03
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

INJECTAFER · ReferencePrescription
FERRIC CARBOXYMALTOSE 750MG IRON/15ML (50MG IRON/ML) · SOLUTION · INTRAVENOUS
INJECTAFER · ReferencePrescription
FERRIC CARBOXYMALTOSE 100MG IRON/2ML (50MG IRON/ML) · SOLUTION · INTRAVENOUS
INJECTAFER · ReferencePrescription
FERRIC CARBOXYMALTOSE 500MG IRON/10ML (50MG IRON/ML) · SOLUTION · INTRAVENOUS
INJECTAFER · ReferencePrescription
FERRIC CARBOXYMALTOSE 1GM IRON/20ML (50MG IRON/ML) · SOLUTION · INTRAVENOUS

Approval history

2025-01-03Labeling · Supplement 27 · standard — Label ↗AP
2023-05-31Labeling · Supplement 24 · standard — Letter ↗AP
2023-05-31Efficacy · Supplement 20 · standard — Letter ↗AP
2022-02-04Manufacturing (CMC) · Supplement 19 · standard — Label ↗AP
2021-11-19Efficacy · Supplement 16 · standard — Label ↗AP
2021-08-04Labeling · Supplement 17 · standard — Letter ↗AP
2021-04-28Efficacy · Supplement 14 · standard — Letter ↗AP
2020-10-08Manufacturing (CMC) · Supplement 12 — Letter ↗AP
2020-09-11Labeling · Supplement 13 · standard — Letter ↗AP
2020-02-19Labeling · Supplement 9 · standard — Letter ↗AP
2018-10-25Labeling · Supplement 8 · standard — Label ↗AP
2018-01-26Efficacy · Supplement 5 · priority — Label ↗AP
2015-12-03Manufacturing (CMC) · Supplement 3 · standardAP
2015-11-16Manufacturing (CMC) · Supplement 4 · standardAP
2014-11-16Manufacturing (CMC) · Supplement 1 · standardAP
2013-07-25Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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